(32 days)
The Neptune E-SEP is an Integrated Smoke Evacuation Pencil) designed for general electrosurgical applications including cutting and coagulation, and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system. The pencil enables the operator to remotely conduct an electrosurgical current from the output connector of an electrosurgical unit (generator) to the operative site for the desired surgical effect.
The Stryker® Neptune® E-SEPT™ Smoke Evacuation Pencil is a single use monopolar electrosurgical pencil that includes a handpiece with a smoke evacuation function and a range of electrodes (both uncoated and coated). The electrosurgical pencil is compact in size (190 mm long and 17 mm diameter) with 3 m of plastic smoke evacuation tubing and associated electrical cable housed within the tubing. The device is externally powered via an external power generator (supplied by user) connected to a monopolar receptacle using a conventional 3-pin connector. This device remains unchanged from the cleared predicate pencil.
The Stryker® Neptune® E-SEPT™ Smoke Evacuation Pencil is available in two activation switch configurations, a rocker style and push-button style, which activates monopolar cut or coagulate functions operated by pressing the respective button. The pencil is connected to smoke evacuation tubing which features a dual connector (8 and 22 mm) to allow the user to connect to a variety of smoke evacuation systems including filtration or central vacuum systems, thus minimizing exposure of personnel to surgical smoke plume.
Electrodes are available in Blade, Needle, Ball, T-Bar Loop, U-Bar Loop and Conization geometries and are listed in Table 6-1 below
This document details the acceptance criteria and study findings for the Stryker Neptune E-SEP Smoke Evacuation Pencil, a medical device for electrosurgical applications.
The information below is based on the provided 510(k) Summary (K153679).
1. Table of Acceptance Criteria and Reported Device Performance
| Test Area | Acceptance Criteria (Implied by equivalence to predicate and industry standards) | Reported Device Performance |
|---|---|---|
| Electrical Safety | Compliance with IEC 60601-1 and IEC 60601-2-2 (General requirements for basic safety and essential performance of medical electrical equipment) | Tests demonstrated compliance with IEC 60601-1 and IEC 60601-2-2. |
| Functional / Performance | Deliver intended electrosurgical cutting and coagulation, and effectively evacuate smoke. Consistent performance with predicate device. | Tests demonstrated functionality, integrity, and safety/effectiveness for intended use, supporting substantial equivalence. |
| Thermal Spread | Thermal characteristics consistent with the predicate device and within acceptable safety limits. | Testing was conducted to evaluate thermal spread, and results supported substantial equivalence. (Specific numerical criteria/results not provided beyond a general statement of sufficiency) |
| Biocompatibility | Materials used are biocompatible and do not pose undue risk to patients or users. Compliance with relevant biocompatibility standards. | Biocompatibility testing was performed, and results supported substantial equivalence. |
| Sterilization & Packaging | Device remains sterile, and packaging maintains sterility until point of use. Sterility Assurance Level (SAL) of $10^{-6}$. | Sterilization and packaging testing confirmed sterile single use, EtO sterilization with SAL = $10^{-6}$, and maintained sterility. |
| Mechanical Integrity | Electrodes and pencil maintain structural integrity during use. Suitable for electrosurgical applications. | Testing demonstrated the integrity of the electrodes. (Specific criteria/results not provided beyond a general statement of sufficiency) |
| Material Equivalence | New materials (ABS Plastic, 304 Series Stainless Steel) do not negatively impact safety or performance compared to predicate materials. | Performance testing (including electrical and functional) covered devices with new materials, confirming their suitability. |
| Working Length Equivalence | Longer electrode working lengths (70mm - 165mm) perform comparably to predicate (70mm) in terms of safety and effectiveness. | Performance testing covered various working lengths, supporting similar safety and effectiveness. |
| Geometry Equivalence | New electrode geometries (Needle, Ball, T-Bar Loop, U-Bar Loop, Conization) perform comparably to predicate (Blade, Needle-compatibility) in safety and effectiveness. | Performance testing covered various geometries, supporting similar safety and effectiveness. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes (number of devices or tests) for each non-clinical test conducted. It states that "Performance testing was conducted on the proposed devices as determined by the risk analysis for the products."
The data provenance is from non-clinical bench testing performed by the manufacturer, Stryker Instruments. The country of origin for the data is not explicitly stated but is implicitly associated with the manufacturer's testing facilities. The tests are prospective in the sense that they were conducted specifically for this 510(k) submission to demonstrate the performance of the modified device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This submission relies on non-clinical performance testing (bench testing) rather than studies involving expert interpretation of medical images or diagnostic outcomes. Therefore, there were no experts used to establish ground truth in the traditional sense of clinical or diagnostic studies. The "ground truth" for these engineering and performance tests is defined by established engineering standards (e.g., IEC standards) and the performance characteristics of the predicate device.
4. Adjudication Method for the Test Set
As this was non-clinical bench testing, an adjudication method for a "test set" in the context of expert review or consensus (like 2+1 or 3+1) is not applicable. The outcome of each test was determined by whether the device met the pre-defined engineering and performance specifications.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This submission pertains to a medical device's electrosurgical and smoke evacuation capabilities, and the modifications are extensions of electrodes and material changes. Clinical studies, including MRMC studies, were deemed "not necessary for this 510(k)." The comparison was primarily based on non-clinical performance data and substantial equivalence to the predicate device.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done
This device is an electrosurgical pencil, a physical medical instrument. Therefore, the concept of "standalone (algorithm only without human-in-the loop performance)" as it applies to AI/software devices is not applicable. The performance testing described is inherently for the device itself.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical performance tests was established by:
- Engineering and Performance Standards: Compliance with recognized international standards such as IEC 60601-1 and IEC 60601-2-2 for electrical safety.
- Predicate Device Performance: The functional, thermal, biocompatibility, and sterilization performance of the legally marketed predicate device (SafeAir Smoke Pencil, K143145) served as the benchmark for substantial equivalence. The proposed device's performance was compared to ensure it was at least as safe and effective.
8. The Sample Size for the Training Set
This medical device is a physical instrument, not an AI or machine learning algorithm. Therefore, the concept of a "training set" in the context of data for model development is not applicable.
9. How the Ground Truth for the Training Set Was Established
As explained above, there is no training set for this type of medical device submission.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem that features a stylized representation of three human profiles facing to the right, stacked on top of each other.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 22, 2016
Stryker Corporation Mairead Twomey Senior Staff Regulatory Affairs Specialist 4100 E. Milham Avenue Kalamazoo, Michigan 49001
Re: K153679
Trade/Device Name: Stryker Neptune E-SEP Smoke Evacuation Pencil Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI Dated: December 18, 2015 Received: December 21, 2015
Dear Mairead Twomey:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
{1}------------------------------------------------
the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Jennifer R. Stevenson -S
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Neptune® E-SEP™ Smoke Evacuation Pencil
Type of Use (Select one or both, as applicable)
Indications for Use (Describe)
The Neptune E-SEP is an Integrated Smoke Evacuation Pencil) designed for general electrosurgical applications including cutting and coagulation, and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system. The pencil enables the operator to remotely conduct an electrosurgical current from the output connector of an electrosurgical unit (generator) to the operative site for the desired surgical effect.
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) | |
|---|---|---|
| -- | --------------------------------------------------------------------------------------------------------------------------------------- | -------------------------------------------------------------------------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response including the
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (8/14)
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
{3}------------------------------------------------
Image /page/3/Picture/2 description: The image shows the word "stryker" in a bold, sans-serif font. The word is all lowercase, and there is a registered trademark symbol to the right of the "r". The letters are thick and evenly spaced, giving the word a strong and recognizable appearance.
510(k) Summary
| Contact Details | |
|---|---|
| 510(k) Owner | Stryker Instruments4100 E. Milham AvenueKalamazoo, Michigan 49001 USAPh: +353-21-4532988Fax: +1-269-324-5412 |
| FDA EstablishmentRegistration No. | 1811755 |
| Contact Person | Mairead TwomeySenior Staff Regulatory Affairs SpecialistPh: +353-21-4532988Fax: +1-269-389-5412Mairead.Twomey@stryker.com |
| Date Submitted | December 18, 2015 |
| Device Name | |
| Trade Name | Stryker® Neptune® E-SEP™ Smoke Evacuation Pencil |
| Common Name | Electrosurgical cutting and coagulation device and accessories |
| Classification | Class II |
| Primary ClassificationName | Electrosurgical, cutting & coagulation & accessories(21 CFR 884.4400, Product code GEI) |
| Reason for 510(k)Submission | Special 510(k) – Device modifications and line extension with nochange to fundamental scientific technology or intended use |
| Device Modification andLine Extension | The line of electrodes offered for use with the Stryker E-SEPPencil will be expanded to include the following: |
| • Addition of different length of electrodes as well as additionalgeometries (Needle, Ball, Wire (Loop T-Bar, Loop U-Bar,Conization) – this is a line extension to enable marketing of amore competitive offering | |
| • New materials present in new offering of electrodes:◦ ABS Plastic (Polylac PA-757) has been added as a plasticover-mold for longer electrodes◦ Different grade of stainless steel for the rod and tip of the barand wire [Loop T-Bar, Loop U-Bar, Conization] electrodes | |
| This line extension does not change the intended use, indicationsfor use or the fundamental scientific technology of the system. |
{4}------------------------------------------------
Image /page/4/Picture/2 description: The image shows the logo for Stryker, a medical technology company. The logo is in black and white and features the company name in a bold, sans-serif font. A registered trademark symbol is located to the upper right of the name.
| Legally Marketed Predicate Device(s) | |||
|---|---|---|---|
| 510(k) NumberPredicate | Product Code | Trade Name | Manufacturer |
| K143145 | GEI | SafeAir Smoke Pencil* | Lina Medical Aps |
| *SafeAir Smoke Pencil is currently marketed as Stryker® Neptune® E-SEPT™ Smoke Evacuation Pencilafter acquisition by Stryker in 2014. | |||
| These predicate devices have not been the subject of a design related recall. | |||
| Indications for Use | |||
| The Neptune E-SEP is an Integrated Smoke Evacuation Pencil (pencil)designed for general electrosurgical applications including cutting andcoagulation, and for removing smoke generated by electrosurgerywhen used in conjunction with an effective smoke evacuation system.The pencil enables the operator to remotely conduct an electrosurgicalcurrent from the output connector of an electrosurgical unit(generator) to the operative site for the desired surgical effect. | |||
| Device Description | |||
| The Stryker® Neptune® E-SEPT™ Smoke Evacuation Pencil is a single usemonopolar electrosurgical pencil that includes a handpiece with asmoke evacuation function and a range of electrodes (both uncoatedand coated). The electrosurgical pencil is compact in size (190 mm longand 17 mm diameter) with 3 m of plastic smoke evacuation tubing andassociated electrical cable housed within the tubing. The device isexternally powered via an external power generator (supplied by user)connected to a monopolar receptacle using a conventional 3-pinconnector. This device remains unchanged from the cleared predicatepencil.The Stryker® Neptune® E-SEPT™ Smoke Evacuation Pencil is available intwo activation switch configurations, a rocker style and push-buttonstyle, which activates monopolar cut or coagulate functions operatedby pressing the respective button. The pencil is connected to smokeevacuation tubing which features a dual connector (8 and 22 mm) toallow the user to connect to a variety of smoke evacuation systemsincluding filtration or central vacuum systems, thus minimizingexposure of personnel to surgical smoke plume.Electrodes are available in Blade, Needle, Ball, T-Bar Loop, U-Bar Loopand Conization geometries and are listed in Table 6-1 below |
{5}------------------------------------------------
Image /page/5/Picture/2 description: The image shows the word "stryker" in a bold, sans-serif font. The word is all lowercase, and the letters are closely spaced together. A small, circled "R" symbol is located to the upper right of the word, indicating that it is a registered trademark. The background of the image is plain white.
| Model Numbers | Model Descriptions |
|---|---|
| 0703-070-000 | Neptune ® E-SEP ™ 70mm Blade Electrode Coated * |
| 0703-070-001 | Neptune ® E-SEP ™ 70mm Blade Electrode * |
| 0703-125-000 | Neptune ® E-SEP ™ 125mm Blade Electrode Coated |
| 0703-125-001 | Neptune ® E-SEP ™ 125mm Blade Electrode |
| 0703-165-000 | Neptune ® E-SEP ™ 165mm Blade Electrode Coated |
| 0703-165-001 | Neptune ® E-SEP ™ 165mm Blade Electrode |
| 0703-007-070 | Neptune ® E-SEP ™ 70mm Needle Electrode |
| 0703-120-003 | Neptune ® E-SEP ™ 3mm Ball Electrode |
| 0703-120-005 | Neptune ® E-SEP ™ 5mm Ball Electrode |
| 0703-213-015 | Neptune ® E-SEP ™ Conization Electrode W13 D15 L120 |
| 0703-213-020 | Neptune ® E-SEP ™ Conization Electrode W13 D20 L120 |
| 0703-216-008 | Neptune ® E-SEP ™ Conization Electrode W16 D8 L120 |
| 0703-216-018 | Neptune ® E-SEP ™ Conization Electrode W16 D18 L 120 |
| 0703-220-020 | Neptune ® E-SEP ™ Conization Electrode W20 D20 L120 |
| 0703-310-010 | Neptune ® E-SEP ™ Loop T-bar Electrode W10 D10 L120 |
| 0703-315-012 | Neptune ® E-SEP ™ Loop T-bar Electrode W15 D12 L120 |
| 0703-320-015 | Neptune ® E-SEP ™ Loop T-bar Electrode W20 D15 L120 |
| 0703-320-020 | Neptune ® E-SEP ™ Loop T-bar Electrode W20 D20 L120 |
| 0703-620-015 | Neptune ® E-SEP ™ Loop T-bar Electrode W20 D15 L60 |
| 0703-620-020 | Neptune ® E-SEP ™ Loop T-bar Electrode W20 D20 L60 |
| 0703-720-020 | Neptune ® E-SEP ™ Loop U-Bar Electrode W20 D20 L120 |
{6}------------------------------------------------
Image /page/6/Picture/2 description: The image shows the logo for Stryker, a medical technology company. The logo is in black and white and features the word "stryker" in a bold, sans-serif font. A registered trademark symbol is located to the right of the word.
| Performance Data(Non-Clinical Tests) | The results of the performance testing demonstrate that thefunctionality, integrity, and safety and effectiveness of the electrodesfor use with the Neptune E-SEP pencil is sufficient for their intendeduse and support a determination of substantial equivalence to thepredicate device. | |
|---|---|---|
| Summary of PerformanceTesting | Performance testing was conducted on the proposed devices asdetermined by the risk analysis for the products. The following areaswere evaluated:Electrical Safety Testing Functional / Performance Testing Thermal spread testing Biocompatibility testing Sterilization and packaging testing Results of these tests demonstrate that the functionality, integrity, andsafety and effectiveness of the subject devices are sufficient for theirintended use and support a determination of substantial equivalence. | |
| Clinical Tests | No clinical testing was deemed necessary for this 510(k). |
{7}------------------------------------------------
Image /page/7/Picture/1 description: The image contains the text "510(k) Summary for K153679" on the left side of the image. To the right of the text is the Stryker logo. The Stryker logo is in bold, black font. There is a registered trademark symbol to the right of the logo.
Table 6-2: Summary of Predicate Comparison
| Description | SafeAir Smoke Pencil [Predicate] K143145(Currently marketed as the Neptune® E-SEP™Smoke Evacuation Pencil) | STRYKER® E-SEP Pencil [Proposed] | Explanationof Difference | |
|---|---|---|---|---|
| Regulatory Information | 510(k) | K143145 | Not yet assigned | N/A |
| Product Code | GEI | GEI | Same | |
| Indication forUse | SafeAir Smoke Pencil is designed for generalelectrosurgical applications including cutting andcoagulation, and for removing smoke generated byelectrosurgery when used in conjunction with aneffective smoke evacuation system. The pencilenables the operator to remotely conduct anelectrosurgical current from the output connectorof an electrosurgical unit to the operative site forthe desired surgical effect. | The Neptune E-SEP is an Integrated Smoke Evacuation Pencil(pencil) designed for general electrosurgical applicationsincluding cutting and coagulation, and for removing smokegenerated by electrosurgery when used in conjunction with aneffective smoke evacuation system. The pencil enables theoperator to remotely conduct an electrosurgical current fromthe output connector of an electrosurgical unit (generator) tothe operative site for the desired surgical effect. | Same.StrykerCorporationacquired theSafeAirSmoke Pencilin 2014. | |
| Classification ofDevice | Class II | Class II | Same | |
| RegulationNumber | 21 CFR 884.4400 | 21 CFR 884.4400 | Same | |
| RegulationName | Electrosurgical cutting and coagulation device andaccessories | Electrosurgical cutting and coagulation device and accessories | Same | |
| Condition ofUse | Single Use | Single Use | Same | |
| Type of Use | Prescription Use Only | Prescription Use Only | Same | |
| PatientPopulation | General | General | Same | |
| Contra -indications | Do not use monopolar electrosurgery on smallappendages, as in circumcision or finger surgery. | Do not use monopolar electrosurgery on small appendages, asin circumcision or finger surgery. | Same | |
| Description | SafeAir Smoke Pencil [Predicate] K143145(Currently marketed as the Neptune® E-SEP™Smoke Evacuation Pencil) | STRYKER® E-SEP Pencil [Proposed] | Explanationof Difference | |
| Overall Design | Device designed to integrate smoke evacuationinto electrosurgery by combining both featuresinto a single handpiece. | Device designed to integrate smoke evacuation intoelectrosurgery by combining both features into a singlehandpiece. | Same | |
| Overall Design Concept | Power Supply | Monopolar Generator supplied by user | Monopolar Generator supplied by user | Same |
| Voltage Rating | Maximum 6.0 kV peak | Maximum 5.5 kV peak | Similar | |
| ElectricalConnector | US-3-Pin | US-3-Pin | ||
| Electrical SafetyTesting | IEC 60601-1IEC 60601-2-2 | IEC 60601-1IEC 60601-2-2 | ||
| Sterility | Sterile Single Use Only, EtO sterilizedSAL = $10^{-6}$ | Sterile Single Use Only, EtO sterilizedSAL = $10^{-6}$ | Same | |
| Packaging | Single pencil unit with preassembled blade andsuction sleeve, holster and clip in an individualTyvek sealed pouch, sold 10 per box. | Single pencil unit with preassembled blade and suction sleeve,holster and clip in an individual Tyvek sealed pouch, sold 10 perbox.Electrodes will also be offered individually packaged in a Tyveksealed pouch, sold 10 per box. | Similar | |
| Description | SafeAir Smoke Pencil [Predicate] K143145(Currently marketed as the Neptune® E-SEP™Smoke Evacuation Pencil) | STRYKER® E-SEP Pencil [Proposed] | Explanationof Difference | |
| Electrode RodMaterial | 303 Series Stainless Steel. | 303 Series Stainless Steel.This material is being used in 7 of the 21 new electrode rods.The rods of the blade and needle electrodes are made from 303series Stainless Steel. | Same | |
| This grade of stainless steel was not present in thepredicate device. | 304 Series Stainless SteelThis material is being used in the remaining 14 of the 21 newelectrode rods. The rods of the ball, conization and loopelectrodes are made from 304 series Stainless Steel. | Similar | ||
| Electrode RodDiameter | 2.36 mm | 2.36 mm | Same | |
| Electrode Technology and Materials | ElectrodeConnectorFeature | Pentagon ConnectorImage: green pentagon connector | Pentagon ConnectorImage: green pentagon connector | Same |
| ElectrodeConnectorMaterial | Polypropylene (Bormed RF830MO)70 mm blade coated | Polypropylene (Bormed RF830MO)70 mm blade coated &70 mm needle | Same | |
| ElectrodeConnectorMaterial | H1500 Polypropylene70mm Blade Electrode (uncoated) | H1500 Polypropylene70mm Blade Electrode (uncoated) | Same | |
| Connector material (ABS Polylac PA-757) was notpresent on the predicate device. | ABS Polylac PA-757 (ABS Plastic) – new connector materialpresent on the Blade, Conization, T-Bar & U-Bar Loop, Ballelectrodes.Image: Electrode Connector | Different | ||
| Description | SafeAir Smoke Pencil [Predicate] K143145(Currently marketed as the Neptune® E-SEP™Smoke Evacuation Pencil) | STRYKER® E-SEP Pencil [Proposed] | Explanationof Difference | |
| Electrode Technologyand Materials | Electrode OverMold Insulation(only applicableto longerelectrodelengths) | Insulation material (ABS Polylac PA-757 ) was notpresent on the predicate device | ABS Polylac PA-757 is present on longer length electrodesincluding the 125mm, 165 mm Blade Electrodes, BallElectrodes, Needle Electrode, T-bar and U-bar Loop Electrodesand the Conization Electrodes.Image: Electrode Over Mold Insulation | Different |
| Electrode tipmaterial | 303 Series Stainless Steel | 303 Series Stainless SteelThis material is being used in 7 of the 21 new electrode tips.The tips of the blade and needle electrodes are made from 303series Stainless Steel. | Same | |
| This grade of stainless steel was not present in thepredicate device. | 302 Series Stainless Steel304 Series Stainless Steel | Similar | ||
| Electrode tipcoating | PTFE (Polytetraflouroethylene) | PTFE (Polytetrafluoroethylene) | Same | |
| Electrode tipworking length | 70 mm | 70 mm - 165 mm | Different | |
| Electrode tipgeometry | Blade (coated and uncoated)Image: Electrode tip geometry | Blade (coated and uncoated)Image: Electrode tip geometry | Same | |
| Description | SafeAir Smoke Pencil [Predicate] K143145(Currently marketed as the Neptune® E-SEP™Smoke Evacuation Pencil) | STRYKER® E-SEP Pencil [Proposed] | Explanationof Difference | |
| Electrode tipgeometry | NeedleCompatibility with the Colorado MicroDissectionneedle was cleared previously | NeedleImage: Needle | Same | |
| Not applicable – these geometries were notpreviously cleared | U-Bar, T-Bar, Conization and BallImage: U-Bar, T-Bar, Conization and Ball | Different |
{8}------------------------------------------------
Image /page/8/Picture/1 description: The image shows the text "510(k) Summary for K153679" on the top left. To the right of this text is the Stryker logo. The Stryker logo is in black and has a registered trademark symbol next to it.
{9}------------------------------------------------
Image /page/9/Picture/1 description: The image shows the title "510(k) Summary for K153679" on the left side of the image. On the right side of the image is the Stryker logo. The Stryker logo is in bold, black font and has a registered trademark symbol next to it.
{10}------------------------------------------------
Image /page/10/Picture/1 description: The image contains the text "510(k) Summary for K153679" on the left side of the image. To the right of the text is the Stryker logo. The Stryker logo is in bold black font with a registered trademark symbol.
{11}------------------------------------------------
Image /page/11/Picture/1 description: The image shows the text '510(k) Summary for K153679' on the left side. On the right side of the image is the Stryker logo. The Stryker logo is in black and has a registered trademark symbol.
{12}------------------------------------------------
Image /page/12/Picture/2 description: The image shows the word "stryker" in a bold, sans-serif font. The letters are all lowercase, and the word is black. There is a registered trademark symbol to the right of the word. The word is likely a company logo.
Conclusion/Substantial Equivalence Rationale
The Stryker E-SEP Pencil and Accessories are either identical or similar in intended use, indications for use, technological characteristics, safety and effectiveness to the previously cleared Pencil. The products have the same fundamental scientific technology, basic design, functional characteristics and applications. The modifications and line extension of electrodes introduced raise no new issues of safety and effectiveness.
Therefore, the subject device is at least as safe and effective as the predicate and evidence supports a determination of substantial equivalence.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.